EBM Journal Club 網球肘與雷射治療 EBM...指導醫師: 顏宏融醫師 楊宗憲醫師...
Transcript of EBM Journal Club 網球肘與雷射治療 EBM...指導醫師: 顏宏融醫師 楊宗憲醫師...
2011/11/21
A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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雷射針灸治療網球肘是否有效?
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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實證醫學五步驟: 5A / 問查讀用審
Asking: 提出可回答的臨床問題
Assessing: 搜尋最佳實證文獻資料
Appraisal: 謹慎的文獻評讀
Apply: 臨床應用
Auditing: 評估改善
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STEP 1 – Asking 提出問題
雷射針灸治療網球肘是否有效?
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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PICO
P Patient
Problem
Population
Lateral epicondylitis
Lateral elbow tendinopathy
Tennis elbow
I Intervention Laser acupuncture
C Comparison Placebo
Non-laser intervention
O Outcome Pain relief
Function improvement
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肱骨外上髁炎(網球肘) 名稱
Tennis elbow
Lateral epicondylitis
Lateral elbow tendinopathy (tendinosis慢性肌腱損傷)
流行病學:
好發年齡在35歲以上,通常發生在慣用手
盛行率:
一般族群: 1-3%
網球運動員: 10.6%(業餘者較多)
好發族群:
手臂高舉過頭部的職業運動員
工作或生活上需要前臂經常用力旋轉、反覆敲打或提舉重物
黃雅萍, 漫談肱骨外上髁炎的診療, 台北市醫師公會會刊, vol.51, no.1, 2008, p28-31
Neeru,Jaianthi, Epicondylitis (tennis and
golf elbow),Uptodate, 2011,oct
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肱骨外上髁炎(網球肘)
病因: 腕部伸展肌群及旋後肌群的過度使用
病生理學:
纖維母細胞退化
血管新生
僅有少量發炎細胞
症狀:
伸肌群肌腱附著於肱骨外上髁處疼痛
橈側伸腕短肌(extensor carpi radialis brevis
muscle)
伸指肌(extensor digitorum communis muscle)
影響肘腕部伸展及功能性的活動
黃雅萍, 漫談肱骨外上髁炎的診療, 台北市醫師公會會刊, vol.51, no.1, 2008, p28-31
Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med 1992; 11:851.
2011/11/21 9 Copyright © The Journal of Bone & Joint
Surgery, Inc. All rights reserved.
From: Current Concepts Review - Tendinosis of the Elbow (Tennis Elbow). Clinical Features and Findings of
Histological, Immunohistochemical, and Electron Microscopy Studies*
The Journal of Bone and Joint Surgery (American) 1999; 81:259-278
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肱骨外上髁炎(網球肘)
檢查
理學檢查
手腕做伸展或前臂做旋後的等長阻力測試(resisted isometric test/Cozen’s test)
會誘發疼痛,力量會因疼痛而減弱。
手肘外上髁處會有局部壓痛點
影像學檢查:
軟組織超音波檢查: sensitivity 64-82%
核磁共振造影: sensitivity 90-100%
多用以評估是否需要手術治療
診斷: 病史+PE (+image)
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肱骨外上髁炎治療現況 局部類固醇注射 短期(6週): *
快速顯著緩解疼痛
增加肘部活動量及負重,造成高復發率
中長期:
減少膠原蛋白的合成,進而減少肌腱張力及糖胺多醣基質的形成,增加肌腱退化及斷裂的機率
預後不佳**
非類固醇抗發炎藥物 短期療效不如類固醇*
多以局部外用劑型給藥(降低GI副作用)
體外震波治療
證據不足,正反觀點均有
** Bisset L, Smidt N, Windt DA Van der, Bouter LM, Jull G, Brooks P, et al.: Conservative treatments for tennis elbow do
subgroups of patients respond differently? Rheumatology (Oxford) 2007, 46(10):1601-5.
* Green S, Buchbinder R, Barnsley L, et al. Non-steroidal anti-inflammatory drugs (NSAIDs) for treating lateral elbow
pain in adults. Cochrane Database Syst Rev 2002; :CD003686.
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肱骨外上髁炎治療現況
運動與物理治療
運動治療: 離心運動、牽拉、護具及貼紮
物理治療: 筋膜與軟組織鬆解術、按摩、高電壓直流電刺激、及肌力訓練
手術治療
保守療法6個月以上無效者可考慮
橈側伸腕短肌肌腱清創術
關節鏡治療與開放性手術無顯著差異*
* Neeru,Jaianthi, Epicondylitis (tennis and golf elbow),Uptodate, 2011,oct
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STEP 2 – Assessing 搜尋資料
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Laser acupuncture, tennis elbow
Medline
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搜尋技巧(1)
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搜尋技巧(2)
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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Laser acupuncture AND tennis elbow
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PubMed
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雷射
Laser = Light Amplification by
Stimulated Emission of Radiation
定義: 將激發放射產生的光能,不斷放大而產生單一波長的平行光束
光反應: 因功率密度 (Power Density)
和照射時間 (Exposure time) 而不同
光熱反應 (Photothermal interaction)
光剝離反應 (Photoablation interaction)
光崩解反應 (Photobreakdown interaction)
光化學反應 (Photochemical interaction)
溫度 效應
37-50℃
Hyperthermia
加熱
>60℃ Coagulatuon
凝固
70-90℃ Welding
熔合
100-150℃ Vaporization
蒸發
>200℃ Carbonization
碳化
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雷射
波長: 不同組織對不同波長的光能吸收有所差異
人體內的黑色素及血紅素對波長 810-980nm的光能吸收顯著
水分和硬組織則對Er:YAG,ErCr:YSGG雷射波長有不錯的反應。
一般而言,波長越長,穿透能力越強
能量:
Fluence能量密度 (J/cm2)=[Watts瓦 ( J/sec) x時間 (sec)]/ cm2
雷射針灸: 低能量雷射(Low Level Laser)
氦氖HeNe雷射(波長632.8nm)
砷化鎵GaAs雷射 (波長904nm)
雅克Nd:YAG雷射 (波長1064nm)
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Low Level Laser Therapy (LLLT) 低能量雷射
LLLT別名
Cold laser 冷雷射
Soft laser 軟性雷射
波長: 600-1000nm
氦氖雷射(Helium-Neon laser、波長632.8nm)
鎵砷近紅外線雷射(Infra-red laser、波長904nm)
能量:
5-500mw(millwatts)
手術用雷射能量約為300w(用於止血凝固、燒灼及切除組織 )
劑量: <35J/cm2
Low-level laser therapy, Current Procedural Terminology(CPT), 2010, p1-9
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Low level laser therapy(LLLT)低能量雷射
功效: 生物刺激作用(Biostimulation)
促進傷口癒合
止痛
臨床應用
口腔黏膜炎
禿髮症
皮膚分節性白斑
肥胖
腕隧道症候群
Low-level laser therapy, Current Procedural Terminology(CPT), 2010, p1-9
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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Low level laser AND lateral epicondylitis
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Lateral AND (epicondylitis OR elbow tendinopathy) AND low level laser
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網球肘+低能量激光
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網球肘+低能量雷射
解答不同類型臨床問題之最佳研究設計*
Question type
(問題類型)
Study design
(研究設計)
Diagnostic test
診斷性檢驗或檢查
Prospective, blinded cross-sectional study comparing with
gold standard
前瞻性、盲法、與黃金標準進行比較之斷面研究
Prognosis
預後
Cohort study > Case control study > Case series study
世代研究 > 病例對照研究 > 病例系列研究
Etiology
病因
Cohort study > Case control study > Case series study
世代研究 > 病例對照研究 > 病例系列研究
Therapy
治療
Randomised control trial (RCT)
隨機對照試驗
Prevention
預防
Randomised control trial (RCT)
隨機對照試驗
Cost effectiveness
成本效益
Economic analysis
經濟分析
* 李智雄, 文獻評讀, 高雄醫學大學附設醫院實證醫學中心
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PubMed
Medline
Low level laser +
Lateral epicondylitis 網球肘
低能量雷射低能量激光
+
RCT
11
3 8
4
RCT
Systematic
review Systematic
review 2 1
中國期刊全文數據庫
台灣期刊論文索引系統
The Evidence Pyramid
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SCI點數: impact factor
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選擇適合的分類
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STEP 3 – Appraisal 評讀
低能量雷射治療網球肘的系統性回顧及統合分析
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低能量雷射治療肱骨外上髁炎
過去數個研究*認為LLLT治療網球肘無顯著意義。
未曾比較LLLT不同治療步驟、雷射波長或劑量的影響
最近統計LLLT文獻
21/24 controlled laboratory trials有抗發炎效果(87.5%)
31/36 trials有生物刺激效應,加速膠原蛋白合成(86.1%)
* Smidt N, Assendelft WJ, Arola H, Malmivaara A, Greens S, BuchbinderR, et al.: Effectiveness of physiotherapy
for lateral epicondylitis: a systematic review. Ann Med 2003, 35(1):51-62.
* Bisset L, Paungmali A, Vicenzino B, Beller E: A systematic reviewand meta-analysis of clinical trials on physical
interventionsfor lateral epicondylalgia. Br J Sports Med 2005, 39(7):411-22. discussion411–22.
* Stasinopoulos DI, Johnson MI: Effectiveness of low-level lasertherapy for lateral elbow tendinopathy. Photomed
Laser Surg2005, 23(4):425-30.
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文獻搜尋
Randomised controlled clinical trials
關鍵字: [LLLT(∪)] ∩ [Tennis elbow(∪)]
資料庫:
Medline
Embase
Cinahl
PedRo
the Cochrane Controlled Trial Register as advised by Dickersin
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納入標準Inclusion criteria
Diagnosis: lateral elbow tendinopathy
Treatment: LLLT波長介於632-1064nm之間,刺激
韌帶病變處
針灸穴位
激痛點trigger point
Design: RCTs或crossover
Blinding: outcome assessor
Control group
Placebo control group
Other non-laser intervention with >10 person per group
Specific endpoint: 納入後1-52週需評估疼痛或健康狀態
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Potentially relevant articles
(n=1299)
Articles retrieved for
more detailed evaluation
(n=180)
Articles excluded as irrelevant abstract
(n=1119) 檢閱摘要是否切題
檢閱是否符合Randomization
Articles excluded as not RCTs
(n=162)
RCTs to be included in
the meta-analysis
(n=18)
RCTs with adequate design
(n=15)
檢閱是否符合其他Inclusion criteria條件
RCTs excluded for not meeting
trial design criteria
(n=3)
RCTs excluded for not meeting criteria
of valid procedures for laser treatment
(n=2) RCTs with adequate
treatment procedures
(n=13)
檢閱是否符合治療方法
Quorom flow chart of reviewing process
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未符合Trial Design Inclusion Criteria
對照組僅有3個患者罹患網球肘
對照組只有bilateral condition有給placebo treatment
且資料不完整
未符合blinding
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13 eligible RCT after exclusion
n=13 N=730
Acupoint=2
Tendon=11
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Bias analysis
Positive bias detection
Methodological score (以PEDro scale評分,滿分為10分)
Profit funding source 資金來源
Negative bias detection
Patient selection Long symptom duration 症狀持續21週以上
Recent steroid injection 大於20%患者收案前曾使用類固醇注射
Effective co-interventions 同時接受運動治療
Publication bias
具有顯著意義的文章較有可能被發表
於文獻搜尋過程中,只使用電腦搜尋並且著重在發表的文章,可能會造成發表偏差
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Bias analysis 誤差偵測 種類 結果
Positive
bias
detection
Method score
(Pedro criteria list)
平均6.5分
(僅有一篇低於5分)
Profit funding
source
未提及雷射製造公司
未有作者為雷射製造商會員
Negative
bias
detection
Long symptom
duration
6篇症狀平均大於21週
Recent steroid
injection
5篇患者收案前曾使用類固醇注射
Effective co-
interventions
4篇同時併用運動治療
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Study by first
author
A)
Steroid injections
( > 20%)
B)
Mean
symptom
duration
C)
Mean
baseline
pain
D)
Prior
treatment
failures
E)
Concurrent exercise therapy Deflated effect
size due to
patient
selection bias
Basford [53] 6/23 25 48 ? No Yes (A, B)
Gudmundsen[51] ? 19 ? 134/92* No Possible
(A,C,D)**
Haker [50] 17/25 52 ? 20/25 No Yes (A,B,D)
Haker [46] 18/49* 26 ? 38/49* No Yes (A,B,D)
Krashenninikoff [54] ? 9 55 ? No Possible (A, D)
Lam [55] 0 13 51 0 Eccentric + stretching Possible (E)
Lundeberg [47] 0 > 12 ? ? No Possible (B,C,D)
Løgdberg-Andersson [49] 8/73 26 36 54/73 No Yes (B)* *
Oken [56] 0 (not < 6
weeks before) 24 71 ? Strengthen-ing and
stretching Yes (B,C,E)
Palmieri [57] 0 5 65 0 No No
Papadopoulos [52] 11/14 28 45 21/14 Yes (no details) Yes (A,B,C,D)
Stergioulas [48] 0 6 53 0 Eccentric + stretching No
Vasseljen [58] 5/15 17 43 8/15 No Yes (A, E)
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Publication bias 發表誤差
Funnel plot
漏斗圖
Negative
direction bias
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Publication bias
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Assessment of procedures and treatment variables
Study by first author Laser
wavelength
(nm)
Laser
mean
output
(mW)
Energy
dose per
point (J)
Total
energy
dose per
session (J)
Power
density
(mW/cm2)
Points
irradiated Total
irradiation
time (s)
No.
therapy
sessions
Basford [53] 1064 4080 12.2 12.2 204 7 60 12
Gudmundsen[51] 904 12 1.2 1.2 3 4.6 cm2
area
480 8
Haker [50] 904 12 0.36 2.16 24 6 180 10
Krashenninikoff [54] 830 30 3.6 7.2* 110 ? 120 8 (max.)
Lam [55] 904 25 0.28 0.66 208 2.4 22 9
Løgdberg-Andersson
[49] 904 8 0.25* 0.5 24 2* 62 6
Oken [56] 632 10 6 6 ? 1 600 10
Palmieri [57] 904 3 0.6 1.8 50 3 600 20
Papadopoulos [52] 820 50 3 3 714 1 60 6
Stergioulas [48] 904 40 1.2 7.2 80 6 180 12
Vasseljen [58] 904 1.5 0.9 3.6 6 4 600 8
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Assessment of procedures and treatment variables
Study by first author Laser
wavelength
(nm)
Laser
mean
output
(mW)
Energy
dose per
session (J)
Power
density
(mW/ cm2)
Points
irradiated Total irradiation
time (s) No. therapy
sessions
Haker [46] 904 8 1.20 16 5 150 10
Lundeberg [47] 632/904 1.56/
0.07 0.09 /
0.004 10 11 60 10
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評估方法outcome measure
Primary
Visual analogue scale視覺類比量表(VAS)
Improved global health status
Improved
Good
Better
Much improved
Pain-free
Excellent
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評估方法outcome measure
Secondary
painfree grip strength 無痛握力 (dynamometer,
vigorimeter)
pain pressure threshold 壓痛閾值 (algometer)
sick leave 因不適症狀而無法工作 (days)
Follow-up results
dynamometer vigorimeter algometer
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Meta-analysis of effects – Primary Outcome
the WMD pain reduction on 100mm VAS
17.2mm [95% CI: 8.5 to 25.9] p=0.0001
10.2mm [95% CI: 3.0 to 17.5] p=0.005
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Meta-analysis of effects – Secondary Outcome
the SMD for pain-free grip strength
1.30 [95% CI: 0.91 to 1.68]
0.66 [95% CI: 0.42 to 0.90] p<0.0001
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Disscussion (1)
系統性回顧
搜尋關鍵字更廣
無語言限制
排除品質不佳的RCTs (不符合inclusion criteria)
排除治療方法有問題的RCTs
排除利益團體資金贊助的文章 (v.s 使用藥物治療疼痛的文獻有83%有企業資金贊助*)
統合分析
依低能量雷射的波長及治療部位分組討論
分析可能產生的誤差(bias)
* Bjordal JM, Ljunggren AE, Klovning A, Slordal L: Non-steroidal antiinflammatory drugs, including cyclo-oxygenase-2 inhibitors,
in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ 2004, 329(7478):1317-21.
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Disscussion (2)
使用904nm針對韌帶治療的組別(7 trials),各項結果均有顯著意義
使用632nm針對韌帶治療的組別(1 trial),也有正向結果
穿透深度較淺*
治療劑量較高(6焦耳)
使用830nm或1064nm的組別(3 trials),無顯著意義
治療劑量過高(平均約7.5焦耳)
患者病程較長(2試驗大於21週)
治療前曾注射類固醇的比例較高(2試驗大於20%)
針對中醫穴道治療的組別(2 trials),無顯著意義
此13篇文獻未有副作用相關報導
* Enwemeka CS: Attenuation and penetration depth of red 632.8 nm and invisible infrared 904 nm light in soft
tissues. Laser Therapy 2001, 13:95-101.
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STEP 4 – Applying 臨床應用
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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Q1: 我的病人是否與研究族群差異很大?
不會
選擇病程較短(<21wks),未接受類固醇注射的網球肘病患效果較好
Q2: 研究中的治療是否實際可行?
可以
操作正確波長(904nm)的雷射針灸器械
確認網球肘病患韌帶病變部位
使用低劑量(5-50mW/cm2)治療以達到生物刺激效應
Q3: 治療對於病人的益處和風隩?
可減輕疼痛,改善功能等各項指標
無明顯副作用
Q4: 病人會如何看待這樣的治療?
正向,且大多數病人都能夠接受
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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STEP 5 – Auditing 評估成果
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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目前證據顯示,正確使用雷射針灸對於網球肘患者的疼痛、整體健康程度,以及無痛握力、局部壓痛、工作能力影響、長期預後都有幫助
無菌、無痛、安全、劑量可調整
別擔心! 不會有明顯副作用~
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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未來研究方向
904nm是否為最合適治療網球肘的波長?
[雷射針灸 v.s. 針灸、注射類固醇]的療效比較
雷射針灸是否有更多適應症?
2011/11/21
A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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小結
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A systematic review with procedural assessments and metaanalysis of low level laser therapy in lateral elbow tendinopathy
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Summary
實證醫學可從龐大的醫學資料庫中找出值得信賴的部分: 5A問查讀用審
利用方法學及誤差偵測可篩選出符合需求的文獻。
將所能獲得的最佳文獻證據應用於臨床工作中,使病人得到最佳的照顧: 實證、專業、病患三位一體